Data Foundry

Medical device recalls 2014

ACUSON S Family Ultrasound Systems at software versions VC25D — Class II medical device recall Z-1962-2014

Terminated recall by Siemens Medical Solutions USA, Inc., reported 2014-07-09, distributed in CA, MO, PA, VA, WV. There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S

Recall numberZ-1962-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSiemens Medical Solutions USA, Inc., Mountain View, CA, United States
Recall initiated2014-06-03
Classified2014-07-01
Reported by FDA2014-07-09
Terminated2016-05-25
DistributedCA, MO, PA, VA, WV
Countries outside the USAE, AR, AT, AU, BE, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FR, GB, GR, IL, IN, IQ, IT, JP, KR, MA, MX, MY, NL, NO, PH, PL, PT, RO, SA, SE, SG, SI, SK, TR, TW, UA, ZA
Quantity790 units
Serial numbers200001, 200102, 200113, 200128, 200145, 200157, 200217, 200225, 200264, 200289, 200319, 200327, 200359, 200360, 200365, 200379, 200440, 200620, 200688, 200762, 200908, 200977, 200978, 200983, 201012 and 475 more

Product

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

Reason for recall

There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1962-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.